- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141723
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
June 14, 2018 updated by: Colm Travers, University of Alabama at Birmingham
Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)
The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0°
C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (<32.0°
C) in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care, as practiced.
The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for infants who are ≥37 weeks gestational age (this one).
This term infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants.
The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported.
Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.
Study Type
Interventional
Enrollment (Actual)
423
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lusaka, Zambia
- University Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Estimated gestational age ≥37 0/7 weeks
- Delivery in the hospital
Exclusion Criteria:
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
- Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
- Infants requiring respiratory support beyond 10 minutes after birth
- Infant requiring Neonatal Intensive Care Unit admission
- Cesarean section
- Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: KMC & WHO protocol (0-1 hour)
The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
|
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
|
Active Comparator: KMC & WHO protocol (1-24 hours)
The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
|
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
|
Experimental: KMC, WHO protocol & bag (0-1 hour)
The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
|
In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in.
and 1.2 mil thick) that will cover the infant's torso and lower extremities.
|
Experimental: KMC, WHO protocol & bag (1-24 hours
The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
|
In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate or severe hypothermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
|
Moderate (32.0-35.9C)
or severe (<32.0C)
hypothermia at 1 hour after birth (via axillary temperature)
|
1 hour after birth
|
Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)
Time Frame: 1 to 24 hours after birth
|
Moderate (32.0-35.9C)
or severe (<32.0C)
hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)
|
1 to 24 hours after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Any hypothermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
|
Any hypothermia (<36.5C) at 1 hour after birth
|
1 hour after birth
|
Any hypothermia at 1 hour after birth (Phase 2B)
Time Frame: 1 to 24 hours or discharge
|
Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first
|
1 to 24 hours or discharge
|
Hyperthermia at 1 hour after birth (Phase 2A)
Time Frame: 1 hour after birth
|
Hyperthermia (>38.0C) at 1 hour after birth
|
1 hour after birth
|
Hyperthermia at 1 hour after birth (Phase 2B)
Time Frame: 1 to 24 hours or discharge
|
Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first
|
1 to 24 hours or discharge
|
Skin rash
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
|
Skin rash (at 1 hour and before discharge)
|
1 hour to 24 hours or discharge, or whichever occurs first
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Neonatal Intensive Care Unit admission
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
|
Neonatal Intensive Care Unit admission (at 1 hour and before discharge)
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1 hour to 24 hours or discharge, or whichever occurs first
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Respiratory distress syndrome
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
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Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)
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1 hour to 24 hours or discharge, or whichever occurs first
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Sepsis
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
|
Diagnosis of sepsis (at 1 hour and before discharge)
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1 hour to 24 hours or discharge, or whichever occurs first
|
Hypotension, hypoglycemia or seizure
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
|
Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)
|
1 hour to 24 hours or discharge, or whichever occurs first
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Death
Time Frame: 1 hour to 24 hours or discharge, or whichever occurs first
|
Death (at 1 hour and before discharge)
|
1 hour to 24 hours or discharge, or whichever occurs first
|
Maternal body temperature
Time Frame: At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
|
Maternal body temperature in Celsius
|
At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
|
Duration of KMC and plastic bag to infant's body temperature
Time Frame: During first 1 hour
|
Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius
|
During first 1 hour
|
Duration of KMC and plastic bag to infant's body temperature
Time Frame: During first 24 hours or discharge, or whichever occurs first]
|
Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius
|
During first 24 hours or discharge, or whichever occurs first]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2017
Primary Completion (Actual)
August 12, 2017
Study Completion (Actual)
August 12, 2017
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
May 3, 2017
First Posted (Actual)
May 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 18, 2018
Last Update Submitted That Met QC Criteria
June 14, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F150807003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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